Drug delivery device for pharmaceutical compositions
The present invention relates to a dual-chamber pack with a first chamber comprising a container; and a second chamber comprising a reservoir, a biphasic connector, a plunger, and a plug with a breakable polymeric membrane. The container of the first chamber is prefilled with a pharmaceutically acceptable vehicle and the reservoir of the second chamber is prefilled with a solid composition of an active ingredient, wherein the solid composition of the active ingredient is mixed with the pharmaceutically acceptable vehicle to form a liquid pharmaceutical composition upon activation of the dual-chamber pack.
1. A drug delivery device for the in situ preparation of an extended release oral suspension upon activation of the device, the device comprising:
a) a first chamber comprising a suspension base;
b) a second chamber comprising a solid composition comprising cores of active ingredient coated with a release controlling agent to form coated cores; and
c) a breakable substantially impermeable polymeric membrane separating first and second chamber
wherein, the substantially impermeable polymeric membrane is made up of a polymeric material selected from the group consisting of polyethylene (PE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), high density polyethylene (HDPE) and high barrier grade PE, has a thickness not less than 0.10 mm and a moisture vapor transmission rate less than about 5.0 g/m 2 /day; and
wherein, the solid composition remains stable when stored in the drug delivery device at 40° C./75% RH for at least three months.
2. The drug delivery device of claim 1 , wherein the breakable substantially impermeable polymeric membrane prevents intimate contact between the contents of first and second chamber before activation.
3. The drug delivery device of claim 1 , wherein the second chamber comprises a plunger for storing the solid composition and a plug fitted with the breakable substantially impermeable polymeric membrane.
4. The drug delivery device of claim 3 , wherein after activation of the device, not more than 50% of the circumference of the breakable substantially impermeable polymeric membrane remains attached to the plug to allow free flow of the coated cores from second chamber to first chamber.
5. The drug delivery device of claim 3 , wherein the plunger comprises one or more sharp projections with an essential continuous blunt area at an angle of not more than 60°.